European Health Union: New rules to improve clinical trials in the EU

As of today (31 January), the assessment and supervision of clinical trials throughout the EU will be harmonised, notably via a Clinical Trials Information System (CTIS) run by the European Medicines Agency. On this date, the Regulation on Clinical Trials will enter into application. The Regulation will improve conducting clinical trials in the EU, with the highest standards of safety for participants and increased transparency of trial information. Welcoming this important step, Health and Food Safety Commissioner Stella Kyriakides (pictured) made the following statement: “The Clinical Trials Regulation marks an important and positive step for European patients and brings us closer to a stronger European Health Union. It will allow us to have swifter authorisation of clinical trials across our member states, thus improving the efficiency of clinical research as a whole. At the same time, the high quality and safety standards already set for such trials will be upheld. While almost 4,000 clinical trials are already carried out each year in the EU, the Regulation will make vital research even more beneficial to the researchers and patients who depend on fast and reliable trials the most.” The full statement is available online.

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